NCT05582265View on ClinicalTrials.gov

Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Head and Neck Squamous Cell Carcinoma (REDUCTION-I)

PHASE3RecruitingINTERVENTIONAL
Enrollment

537

Participants

Timeline

Start Date

October 28, 2022

Primary Completion Date

October 31, 2028

Study Completion Date

October 31, 2030

Conditions
Head and Neck Squamous Cell Carcinomas
Interventions
DRUG

Tislelizumab（neoadjuvant）

Tislelizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

DRUG

Cisplatin （neoadjuvant）

Cisplatin 75 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

DRUG

Nab-paclitaxel （neoadjuvant）

Nab-paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

PROCEDURE

Surgical resection

Standard of care

DRUG

Cisplatin（adjuvant）

Cisplatin 100 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

DRUG

Tislelizumab（adjuvant）

Tislelizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

RADIATION

Radiation

Recommended, standard of care

DRUG

Carboplatin (neoadjuvant）

Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

DRUG

Carboplatin (adjuvant）

Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

Trial Locations (3)

510000

RECRUITING

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guanzhou

528400

RECRUITING

Zhong shan people's hospital, Zhongshan

Unknown

RECRUITING

Huazhong University of Science and Technology Union Hospital (Nanshan Hospital), Shenzhen

All Listed Sponsors
collaborator

Zhongshan People's Hospital, Guangdong, China

OTHER

collaborator

Shenzhen Sixth People's Hospital

OTHER

lead

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER